Clinical trial · Interventional
Multiparametric Ultrasound Imaging in Prostate Cancer
Multiparametric Ultrasound (mpUS) as Imaging Modality for the Detection and Localization of Prostate Cancer
NCT03101176CI-TRIAL-00036598unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking. Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SonoVue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Single Arm
- description
- All consenting patients will undergo mpUS imaging prior to surgery with the ultrasound contrast agent Sonovue for the CEUS specific mode.
- interventionNames
- Drug: SonoVue
Primary outcomes (1)
- measure
- Validation of mpUS
- timeFrame
- 5 years
- description
- Predictive accuracy in terms of sensitivity and specificity of mpUS imaging in the detection and localization of prostate cancer by qualitatively and semi-quantitatively correlation of mpUS imaging to corresponding radical prostatectomy histopathology
Secondary outcomes (2)
- measure
- Differences in mpUS parameters between benign and malignant (low-grade and high-grade) prostate tissue
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * biopsy proven prostate carcinoma * planned treatment by (robot laparoscopic) radical prostatectomy * signed informed consent Exclusion Criteria: * Chemotherapy, radiotherapy or focal therapy of the prostate for prostate cancer * Hormonal therapy for prostate cancer within last six months * History of any clinically evidence of cardiac right-to-left shunts * Receives treatment that includes dobutamine * Severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome * Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study * Is incapable of understanding the language in which the information for the patient is given
References
Publications (9)
- BACKGROUNDBjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS. Optimization of initial prostate biopsy in clinical practice: sampling, labeling and specimen processing. J Urol. 2013 Jun;189(6):2039-46. doi: 10.1016/j.juro.2013.02.072. Epub 2013 Feb 26. PMID 23485507
- BACKGROUNDUkimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25. PMID 23021971
- BACKGROUNDBorghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17. PMID 27543165
- BACKGROUNDSchoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. 2015 Sep;68(3):438-50. doi: 10.1016/j.eururo.2014.11.037. Epub 2014 Dec 3. PMID 25480312
- BACKGROUNDMuller BG, Shih JH, Sankineni S, Marko J, Rais-Bahrami S, George AK, de la Rosette JJ, Merino MJ, Wood BJ, Pinto P, Choyke PL, Turkbey B. Prostate Cancer: Interobserver Agreement and Accuracy with the Revised Prostate Imaging Reporting and Data System at Multiparametric MR Imaging. Radiology. 2015 Dec;277(3):741-50. doi: 10.1148/radiol.2015142818. Epub 2015 Jun 18. PMID 26098458
- BACKGROUNDBranger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.